FDA.reportPublic FDA data

NDC 0641-6083-01 - PHENERGAN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0641-6083
Requested NDC
0641-6083-01
Package NDCs from labels
0641-6083-01, 0641-6083-25
Manufacturer
Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2025-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PHENERGAN - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2025-06-30HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6083-01PHENERGAN1 mL in 1 AMPULEINJECTION18
0641-6083-25PHENERGAN25 in 1 CARTONINJECTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6083PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20240606_6f7e47cc-f823-4336-8107-f980e3049617.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6083-01ML - Milliliter0641-6083dfad8183-56c1-4ff4-9a23-6f0c223deddb12012-07-24
0641-6083-25ML - Milliliter0641-60838e6fb053-ab30-49c2-9207-68fef87ea2a312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
PROMETHAZINEACTIVE MOIETYFF28EJQ494PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
PHENOLINACTIVE INGREDIENT339NCG44TVPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 28 · 560 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECardinal Health 107, LLC7ce351d8-47be-4937-aad2-153208c93b532026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA083312
rxcui: 992460
unii: R61ZEH7I1I
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
calcium chlorideCALCIUM CHLORIDESQUARE PHARMACEUTICALS PLC.753c3973-6522-4d33-811b-b63a4e8cc5852026-01-14Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare46b84e0b-78a9-4cde-9f90-e165b54191622026-01-09WarningsExact identifier
unii: 339NCG44TV
Castellani Paint 1.5%PHENOLThe Podiatree Companya10f18e0-b47c-424b-847e-bcc25aa250a42026-01-08WarningsExact identifier
unii: 339NCG44TV
Castellani Paint 1.5%PHENOLThe Podiatree Company5b8cff3c-71d2-418f-a43d-f570aa5408fd2026-01-08WarningsExact identifier
unii: 339NCG44TV
Fortinia IDPHENOLThe Podiatree Company60c88eb7-22fe-4881-e053-2a91aa0a70ce2026-01-08WarningsExact identifier
unii: 339NCG44TV
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Hyperhidrosis Drops 2144HYPERHIDROSIS DROPSProfessional Complementary Health Formulasbca49d5e-6ade-41d5-82f5-1551936d0a3b2026-01-08WarningsExact identifier
unii: Q40Q9N063P
Tap Water Detox 6018TAP WATER DETOXProfessional Complementary Health Formulasae0bca6a-118e-40a2-9108-14fc415524442026-01-08WarningsExact identifier
unii: 339NCG44TV
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: M4I0D6VV5M
Pancreas Drops 5020PANCREAS DROPSProfessional Complementary Health Formulas669a47a1-ae68-4b49-9f21-288314e9eb762026-01-08WarningsExact identifier
unii: Q40Q9N063P
Promethazine and Phenylephrine HCl, and Codeine PhosphatePROMETHAZINE, PHENYLEPHRINE, CODEINEAmneal Pharmaceuticals LLC5f23b254-872b-4e88-91be-710c3ea7687b2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Sodium AcetateSODIUM ACETATEMILLA PHARMACEUTICALS INC.1ea1466d-a492-4056-e063-6394a90a80bf2026-01-07Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCf6ca1097-1c75-c682-e053-6294a90a2bd62026-01-01Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCd9cb1a44-d646-d9e9-e053-2995a90a24ff2026-01-01Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLC075f052e-7f38-7f75-e063-6394a90a512b2026-01-01Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.